Steerable Leaflet Augmentation Implant for Mitral Regurgitation
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Solution Overview
Problem
Current minimally invasive transcatheter technologies fail to adequately treat functional mitral regurgitation (FMR) and disturb native valve dynamics, leading to poor long-term durability, making them unsuitable for high-risk heart failure patients.
Innovation Solution
A steerable implant delivery system is used to deploy a lightweight implant that augments the valve leaflet, providing leaflet extension and covering the regurgitant gap in systole, while allowing unrestricted inflow in diastole, and can be adjusted to fit individual patient anatomy without damaging the native valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If current minimally invasive transcatheter technologies are used to treat functional mitral regurgitation, then the treatment can be performed with less invasiveness, but the treatment fails to adequately address FMR and disturbs native valve dynamics resulting in poor long-term durability
Solution Approach 1:
The implant is designed with differentiated functional zones: a first portion that provides structural support and anchors to the valve annulus, and a second portion that extends to augment the valve leaflet coaptation. This local differentiation allows the implant to address specific pathological aspects (leaflet insufficiency) while preserving overall native valve dynamics, thereby achieving both minimally invasive treatment and long-term durability.
Solution Approach 2:
The implant is divided into distinct segments including an anchor portion and a leaflet extension portion. The anchor portion secures to the valve annulus while the leaflet extension portion augments coaptation. This segmentation enables independent optimization of each function - secure anchoring for durability and leaflet augmentation for adequate FMR treatment - while maintaining minimally invasive deployment.
2Reliability
If an implant is designed to augment the valve leaflet and cover the regurgitant gap, then regurgitation is reduced, but the implant may interfere with unrestricted inflow during diastole
Solution Approach 1:
The implant is designed with dynamic characteristics that allow it to adapt to different phases of the cardiac cycle. During systole, the implant maintains its structure to cover the regurgitant gap and enhance coaptation. During diastole, the implant's flexibility and the natural valve dynamics allow unrestricted inflow. This dynamic behavior ensures regurgitation reduction without compromising forward flow.
Solution Approach 2:
The implant utilizes flexible materials and thin-film structures that can conform to the native valve geometry and dynamics. These flexible components allow the implant to effectively cover regurgitant gaps during systole while remaining sufficiently compliant to permit unrestricted diastolic inflow, thus resolving the contradiction between regurgitation reduction and flow preservation.
Data Source
AI summary
Embodiments described herein relate to an implant delivery system for delivering an implant for reducing heart valve regurgitation. The implant delivery system may include an implant catheter disposed in an inner lumen of a guide catheter. The implant catheter may include one or more hypotubes disposed therein, each hypotube configured to receive an elongate member such as a braided tether. A distal end of the implant catheter may be coupled to an implant holder configured to receive the implant. The implant holder may define one or more channels, each channel configured to receive a portion of a respective elongate member. The elongate members configured to couple the implant to the implant holder and transition the implant between configurations. The implant configured to be disposed around a portion of a leaflet of a heart valve to improve coaptation of the heart valve.